The purpose of this study is to assess the safety and effectiveness of capecitabine before surgery. The study will also help gain more information about the effects of the capecitabine on physical and emotional well-being and how well the participants on capecitabine follow the study drug plan.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
Capecitabine twice daily for 14 days followed by 7 days without taking drug (1 cycle). This schedule is followed for 8 cycles (about 24 weeks).
University of Chicago
Chicago, Illinois, United States
University of Ibadan
Ibadan, Nigeria
Obafemi Awolowo University
Ile-Ife, Nigeria
Overall Clinical Response Rate (OCR)
Overall clinical response rate (OCR) was defined as a proportion of patients with a best response of Complete Clinical Response (CCR) or Partial Clinical Response (PCR). CCR was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease. PCR was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Partial Clinical Response Rate (PR)
Partial Clinical Response (PR) was defined as reduction by at least 50% of the sum of the products of the longest perpendicular diameters of all measurable lesions.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Complete Clinical Response Rate (CCR)
Complete Clinical Response (CCR) was defined as complete disappearance of all measurable malignant disease, and no new malignant lesion, disease-related symptoms, or evidence of evaluable disease.
Time frame: After the first three cycles of therapy, an average of 9 weeks
Complete Pathologic Response Rate (cPR)
Complete Pathologic Response rate (cPR) was defined as the absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery.
Time frame: After the first three cycles of therapy, an average of 9 weeks
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